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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
05/10/2018
Trade Name:
Briviact
Generic Name or Proper Name (*):
brivaracetam
Indications Studied:
Treatment of partial onset seizures (POS) to include patients 4 years to less than 16 years of age
Label Changes Summary:
*Safety and effectiveness of Briviact tablets and oral solution have been established in pediatric patients 4 years to less than 16 years. *Use in these age groups is supported by evidence from adequate and well-controlled studies of Briviact in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 149 pediatric patients 4 years to less than 16 years. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Safety of Briviact injection in pediatric patients has not been established. *Adverse reactions, including psychiatric adverse reactions, were observed in open-label pediatric trials and were generally similar to those observed in adults. *Information on dosing, dosing in pediatric patients with hepatic impairment, PK parameters, adverse reactions, and clinical trial. *Postmarketing study.
PREA(P):
P
Sponsor:
UCB, Inc.
NNPS:
FALSE
Therapeutic Category:
Anticonvulsant
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